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A multicenter randomized phase III study to compare the combination trastuzumab and capecitabine, with or without pertuzumab, in patients with HER2-positive metastatic breast cancer that have progressed after one line of trastuzumab-based therapy in the metastatic setting (PHEREXA)

To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).

Study to investigate the association between the response to a cholinergic challenge with galantamine and the clinical response to subsequent treatment with galantamine in patients with mild to moderate Alzheimer's Disease

We propose to conduct a study in patients with mild to moderate AD where a cholinergic challenge is given in a placebo-controlled, cross-over fashion, prior to onset of treatment with a CEI. Patients will be followed over a period of 6 months to…

A Phase III randomized, open-label study comparing GSK2118436 to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma (BRF113683)

Primary: superiority of GSK2118436 over DTIC with respect to progression-free survival for subjects with BRAF mutation positive metastatic melanoma.Secondary: overall survival, best overall response, duration of response, non-melanoma skin lesions,…

A single blind, randomized, cross-over placebo controlled dose finding study to investigate the pharmacokinetic profile of 3 doses of sublingual testosterone solution and their effect on physiological and subjective arousal in healthy, sexually functional premenopausal women.

Primary objectives:To establish the lowest effective dose using physiological and subjective measures of sexual arousal.To evaluate and compare the pharmacokinetics of testosterone and its metabolites following administration of three (3) doses (0.…

Effects of acute elevation of circulating fatty acids on hepatic lipid accumulation and metabolism in overweight and obese men with non-alcoholic fatty liver disease

The major research objective is:- To examine if acute exercise results in lower hepatic lipid content and further if elevation of plasma FFAs observed during recovery from exercise results in hepatic lipid accumulation.Additional research objective…

The effect of botulinum toxin type A injections in the m. rectus femoris in stroke patients presenting with stiff knee gait

To determine the effect of botulinum toxin type A injections in stroke patients with stiff knee gait.

Effects of high protein intake in obese children

To assess the effects of a 4-week high protein diet on body composition in obese children. Secondary outcomes are whole-body protein turnover, gluconeogenesis, energy expenditure, markers of the metabolic syndrome, appetite sensations,…

The antihypertensive effect of spironolactone in oligo-anuric haemodialysis patients.

1. to study the effect of spironolacton and triamterene on blood pressure in anuric hemodialysis patients.2. to study the effect of treatment on body weight, serum elektrolytes, 24-hours sodium excretion, plasma aldosterone and renin concentrations…

Come closer: a neurobiological analysis of the prosocial effects of MDMA

In this study we will assess these prosocial effects in an objective way i.e. by means of computer tasks and we will investigate the role of two potential mediators and the role of a genotype variant in the mechanism underlying prosocial behavior.…

The effect of P-glycoprotein transport inhibition on brainmechanisms of sedation and cognitive impairment following antihistamines in healthy volunteers.

The objective of the study is to test the effects of the p-glycoproteine transporter on cognitive test in healthy volunteers and to explore the effects of the p-glycoproteine transporter on functional Magnetic Resonance Imaging (fMRI).

Short- and long-term effects of oxytocin on empathy in autistic male adults.

Our study aims at investigating whether male adults with ASD differ from healthy male adults in their neurophysiological responses to positive and negative empathy-evoking pictures when taking oxytocin intranasally once. To this end we will compare…

Properties of dietary fiber and energy intake: An intervention to study the effect of physicochemical properties of dietary fiber on energy intake and underlying mechanisms

To study the effect of pectin in 5 different physicochemical states on ad libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones, gastric emptying rate, feelings of satiety and the method of fiber supplementation.

Alternative APAP Method for Non-invasive Positive Airway Pressure Therapy in OSAHS patients.
Amendment: Mallampati score as a predictor for effective Positive Airway Pressure

1. To investigate whether an adjusted mode of APAP can improve patients adherence in comparison to fixed CPAP in present-day PAP therapy of OSAHS patients.2. To investigate the agreement between the parameters of the CPAP devices and the polygraphy…

A single-blind, double dummy, randomized, multi-dose, two sequence, crossover, study to investigate the effects of Renin Inhibitor (aliskiren 300 mg) on Albuminuria in nondiabetic nephropathy patients treated with ramipril 10 mg and Volume intervention (CSPP100A2260, ARIA study)

Primary: To investigate the effects of 300 mg aliskiren on albuminuria in patients with non-diabeticnephropathy treated with ramipril 10 mg and volume intervention.Secundary: Effects of ramipril and ramipril plus aliskiren. Effects on RAAS…

An fMRI-study on the effects of NicVAX® and placebo on Central Nervous System activation and behaviour following a nicotine challenge.

Main aim; to show that NicVAX attenuates nicotine induced CNS effects on brain activation and cognitive performance relative to placebo. The secondary aim; to evaluate how these changes in CNS stimulation alter subjective measures and the addictive…

Randomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy

In our study we aim to find proof-of-concept that influencing the underlying protein dysfunction can result in clinically relevant improvement of epilepsy.

An Open-label, Dose Escalation, Pharmacodynamic, Pharmacokinetic, and Effect of Food Phase 1 Study of E7820, Administered as a Once Daily and Twice Daily Oral Dose to Determine the Maximum Tolerated Dose in Subjects with Unresectable Solid Tumors

Part A Food Effect StudyPrimary Objective• To determine the effect of a high fat meal on oral bioavailability of 50 mg E7820 in comparison with fasting conditions.Secondary Objectives• To determine the safety and tolerability of E7820.• To determine…

ARA 290 and the ventilatory response to hypoxia and pain responses in healthy volunteers

(1) To assess the effect of ARA 290 on the ventilatory response to hypoxia (and compare the effects to Epo); (2) To assess the effect of ARA 290 on the gradient over the tricuspid valve during hypoxia (and compare the effects to Epo); (3) To assess…

Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance after Multiple Oral Dosing of LY2623091 in Healthy Volunteers

Primary:- to investigate the safety and tolerability of the study drug after multiple oral dosing in healthy volunteersSecondary:- to investigate the effect of the study drug on potassium clearance upon oral potassium challenge after multiple oral…

A double-blind, randomised, placebo-controlled, combined single and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetic, including food interaction, and pharmacodynamic profile of BIA 5-1058, in healthy male volunteers.

Primary to assess the tolerability of the compound after single and multiple oral dosesSecondaryto measure the plasma and urine concentrations of the compound and its metabolites after single and multiple oral doses and to characterise its…